Introduction to current and future protein therapeutics: a protein engineering perspective

Area of Science:

• Biotechnology
• Pharmacology
• Protein Engineering

Background:

• Protein therapeutics and protein engineering emerged in the 1980s, initially using recombinant natural proteins.
• Modifications like glycoengineering and Fc fusion enhanced clinical potential, leading to antibody-based drugs becoming a dominant class.
• Clinical, scientific, and commercial drivers fuel the development of improved protein therapeutics with better efficacy, safety, and delivery.

Purpose of the Study:

• To review the evolution and advancements in protein therapeutics.
• To highlight the strategies and drivers behind developing next-generation protein drugs.
• To discuss emerging protein therapeutic platforms and their potential advantages.

Main Methods:

• Review of historical development and technological advancements in protein therapeutics.
• Analysis of modification strategies including glycoengineering, Fc fusion, and PEGylation.
• Examination of antibody-based drugs, antibody-drug conjugates, bispecific antibodies, and engineered protein scaffolds.

Main Results:

• Antibody-based drugs represent the largest and fastest-growing class of protein therapeutics.
• Advanced engineering strategies are enhancing protein drug performance, such as extended half-life and effector functions.
• Antibody-drug conjugates and bispecific antibodies are nearing clinical success, with novel engineered scaffolds in early development.

Conclusions:

• Protein therapeutics have evolved significantly, with antibody-based drugs leading the field.
• Continued engineering and novel platforms promise more effective and safer protein-based treatments.
• Future protein drugs will likely be highly engineered, offering improved therapeutic profiles and addressing unmet clinical needs.